It looks like STAIR got final notification of FDA conformance in early April.
Just for the records, I had to WRITE most of that shit, probably 1000 or the 1300 pages submitted, and boy wasn’t it a ton of fun with essentially no reward. This is why I didn’t post many blog entries during that time (writers block?).
Anyway, I’m back on the path to do it again for touchpacs, so I’m either the dumbest man alive, or the most insane… time will tell I spoze.
–chitlenz
Device Classification Name system, image processing, radiological
510(k) Number K100236
Device Name STAIR SYSTEMS PACS & DICOM VIEWER
Applicant
STAIR SYSTEMS, INC.
747 cedard hill drive
allentown, PA 18109
Contact james w monroe
Regulation Number 892.2050
Classification Product Code
LLZ
Date Received 02/02/2010
Decision Date 03/29/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Statement/Summary/Purged Status Summary only
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No